GOVX: Coronavirus Collaboration Could Validate Platform

By John Vandermosten, CFA

NASDAQ:GOVX

Having worked on infectious diseases including human immunodeficiency virus (HIV), Lassa Fever, Ebola, Zika among many others, GeoVax Labs (NASDAQ:GOVX) is in a commanding position to develop a vaccine for the coronavirus, now officially designated as SARS-CoV-2. With the emergence of the virus on a global scale beginning in January 2020, GeoVax announced a partnership with the Chinese company BravoVax to develop a vaccine against the coronavirus. GeoVax has spent years developing its virus like particle (VLP) platform which has been oriented to address a broad variety of infectious diseases. Despite the near complete focus on coronavirus at the moment, GeoVax has a much broader offering that focuses on a variety of critical health concerns including cancer, HIV and other infectious diseases. The company has suffered from a difficult financing environment in recent years, but has taken steps to isolate their Immuno-oncology programs from dilution and will seek additional non-dilutive financing to advance their infectious disease programs.

Source: GeoVax Corporate Website

Coronavirus Vaccine

GeoVax’ long history of working with infectious disease provides the education and experience to launch a program for the novel coronavirus now designated SARS-CoV-2. In January 2020, prior to the magnitude of the risks being understood in the Americas, the company began efforts to construct a vaccine candidate using the GV-MVA-VLP platform based on the genetic sequence of the virus provided by Chinese authorities. On January 27th, GeoVax announced a collaboration with BravoVax, a vaccine developer in Wuhan, China. BravoVax has a number of technology platforms, including bacterial fermentation, cell and virus culture, purification, formulation and quality control. While they have not yet produced a Modified Vaccinia Ankara (MVA), they have the necessary infrastructure to do so with a partner that can provide the seed virus. Both companies will work in parallel to advance the vaccine candidate with regulatory authorities following completion of vaccine construction. Animal testing is expected to begin soon, first in China then in the United States. The pair will also pursue government funding for the vaccine efforts from Biomedical Advanced Research and Development Authority (BARDA).

In the Americas and Europe, GeoVax is working with Emergent Biotechnologies and IDT, a global CDMO based in Germany to produce a coronavirus vaccine. At this stage it is too early to know when first clinical trials will start; however, additional funding from government sources will accelerate the process. GeoVax has designed, developed, constructed and characterized its candidate and expects to move into mouse immunogenicity studies. The next steps for vaccine development require the identification of the proper large animal model, followed by additional animal testing, then a move into the clinic. Under an optimistic scenario, clinical work can begin before year end.

In a recent press release, GeoVax highlights the $27 billion of emergency funding that is available from the recent $2 trillion appropriation that is expected to be used in part to develop treatments and vaccines for the pandemic. We anticipate that the coronavirus crisis will open up government funding globally to address infectious disease to a greater degree than has been done in the past.

Immutak Oncology

In September 2019 GeoVax incorporated Immutak Oncology, a wholly owned subsidiary of GeoVax. All of the immuno-oncology (IO) programs pursued by the company will be placed under this corporate umbrella including work with the University of Pittsburgh, ViaMune, Leidos and others. Financing for Immutak will be separate from the GeoVax parent.

GeoVax is developing a cancer vaccine in collaboration with Dr. Olivera Finn, an expert in cancer immunotherapy at the University of Pittsburgh. The target for the cancer vaccine is the cell surface associated mucin 1 (MUC1) protein, a glycoprotein that is associated with colon, breast, ovarian, lung and pancreatic cancers1. Cancer vaccines have a differentiated mechanism of action that can control and clear tumors as wells establish immunological memory that can prevent tumor recurrence.

GeoVax is currently developing its GV-MVA-VLP vaccine platform to express abnormal forms of MUC1 that will be recognized by the immune system thereby producing protective anti-tumor antibodies and T cell responses for cancer patients. Efforts so far have succeeded in breaking tolerance to human MUC1 tumors in transgenic mice, protecting them from a challenge in a lymphoma tumor model.

Another aspect of the IO effort is the collaboration with ViaMune, which has developed a fully synthetic MUC1 vaccine candidate. The goal of the partnership is to construct a vaccine that elicits a broad spectrum of anti-tumor antibody and T cell responses. Combination therapies with checkpoint inhibitors may be used with advanced MUC1 tumors. Progress so far with this relationship has achieved the production of a MVA-VLP-MUC1 vaccine candidate, VLP production evidenced by MUC1 immunogold staining, and the expression of VLPs in a hypo-glycosylated form of MUC1 in human cells. Preclinical work has demonstrated a reduction in tumor burden in a mouse model for colorectal cancer.

GeoVax’ work with Emory Vaccine Center has been underway for almost two years in a relationship that is developing a therapeutic vaccine for human papillomavirus (HPV) infection. Current medicine lacks an approved treatment for HPV, which can result in cancerous tumors. Efforts are now focused on animal testing which are ultimately expected to yield a combination approach for the HPV vaccine with checkpoint inhibitors or other IO candidates.

Virometix, a private Swiss company, is working with GeoVax on an immunotherapy program combining its synthetic virus like particle platform with MVA to design a therapeutic vaccine for HPV. Combination work using the two approaches is underway in animal testing.

Leidos is collaborating with GeoVax to advance a PD-1 checkpoint inhibitor and immunotherapeutic vaccine for cancer, hepatitis B and other indications.

Lassa Fever

The Department of Defense (DoD) awarded $2.4 million to GeoVax in September 2018 for the Lassa fever virus vaccine development program. DoD will also fund testing of the vaccine by US Army scientists at the US Army Medical Research Institute of Infectious Diseases under a subaward. The funds will support work to conduct rodent and nonhuman primate testing, manufacturing process development and current Good Manufacturing Process (cGMP) production of vaccine seed stock for eventual human trials. This effort is being conducted with the US Army and the Geneva Foundation. IN 2019 GeoVax received $674,000 from the US Army and $147,000 from an SBIR grant to fund its Lassa Fever work.

Human Immunodeficiency Virus (HIV)

GeoVax is advancing its GOVX-B11 HIV vaccine which is slated to enter a Phase I trial designated HVTN 132 and managed by the HIV Vaccine Clinical Trials Network (HVTN). The preventative vaccine is focused on the clade B subtype of HIV most common in the Americas, Western Europe, Japan and Australia. GOVX-B11 most recently completed a Phase IIa trial; however, the candidate will revert to an additional Phase I trial to evaluate the safety and immunogenicity of adding a protein boost component of the vaccine. The multi-center, randomized, double-blind trial is anticipated to begin in late 2020 with the support of the HVTN. It is anticipated to enroll 70 patients.

GOVX-B11 should move up a few spots in the rankings given the recent halt of the HVTN 702 clinical trial. This Phase IIb/III study began in South Africa and combined a multi-component vaccine including a canarypox vector-based vaccine (ALVAC-HIV) and a two-component gp120 protein subunit vaccine. These agents were provided by Sanofi Pasteur and GSK respectively. In early February 2020, the National Institute of Allergy and Infectious Diseases (NIAID) halted vaccinations using this regimen. While there were no safety concerns, there was also no evidence that the prime-boost combination prevented HIV.

In collaboration with American Gene Technologies, GOVX-B11 will be combined with AGT103-T, a single dose autologous cell therapy which delivers gene-modified, HIV-specific CD4 T cells to HIV patients. GOVX-B11 will be used in one of the arms of the trial to stimulate virus specific CD4+ T cells in vivo, prior to leukapheresis. Following the separation of white blood cells from patients’ blood and purification of HIV-specific CD4+ T cells, the cells will be genetically modified ex vivo then reinfused in the patient. This trial is expected to begin in 2020 with the goal of providing a functional cure for HIV.

GeoVax will also move forward with its boost component, MVA62B, for use in a collaboration with the University of California, San Francisco (USCF). This effort will evaluate a combination approach employing vaccines, drugs and biologics in a small 20 person trial. Participants will be HIV-infected and stable on anti-retroviral therapy.

Company Pipeline2

Capital Structure

GeoVax has used convertible preferred stock to fund its operations as they pursue more stable capital from other sources. As of September 30, 2019, there was $2.2 million in carrying value of Series H and I convertible preferred stock, which may be redeemed at a discount to trading prices. The carrying value of this security has decreased significantly to $300,000 as of March 23, 2020 representing 300 shares. The current holding of Series J preferred stock was issued January 24, 2020.

Summary

GeoVax has a broad portfolio of assets in infectious disease that provide many opportunities to develop a marketable product. Much of the company’s research and development is funded by government and agency grants. As of the end of the first quarter 2020, GeoVax’ market cap is under $5 million which stands in stark contrast to the hundreds of millions in revenues the company’s assets could generate if even only one program is successful. GeoVax offers immuno-oncology, HIV, Lassa Fever, Ebola, Marburg, Sudan, Zika and other programs that with the proper funding and development have a fair chance to receive regulatory approval and be commercialized. We see picking up GeoVax for a few million dollars and a capital infusion of $20 to $30 million more providing a clear pathway to proof of concept for vaccines to address some of the world’s most feared diseases.

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1. Gendler, S. MUC1, The renaissance molecule. Journal of Mammary Gland Biology and Neoplasia 6(3):339-53 · August 2001.

2. Source: GeoVax Company website, accessed March 31, 2020. https://www.geovax.com/technology-pipeline/pipeline-summary

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